paroxysmal nocturnal hemoglobinuria
Conditions
Interventions
Control test:methylprednisolone 0.8mg/kg.d
experimental group:Tretinoin 0.33mg/kg.d
methylprednisolone 0.8mg/kg.d
Sponsors
Department of Hematology, Second Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients with paroxysmal nocturnal hemoglobinuria who were clinically diagnosed within 30 days before enrollment; (2) Male and female PNH patients aged 14 years and above; (3) Received regular treatment (including adrenal glucocorticoid treatment for 1 year, etc.), according to the efficacy evaluation standard "Paroxysmal nocturnal hemoglobinuria diagnosis and treatment Chinese expert consensus" (Chin J Hematol, March 2013, Vo1.34 , No. 3) PNH patients diagnosed as ineffective or relapsed; (4) Estimated survival time > 24 weeks, and ECOG score 0-2; (5) Have not participated in other clinical trials within four weeks; (6) The clinician believes that the patient does not need to initiate clinical treatment immediately; (7) PNH patients who can comply with the protocol and medication requirements based on the judgment of the investigator; (8) Sign a dated informed consent form before the start of a specific drafting step.
Exclusion criteria
Exclusion criteria: (1) Suffer from other types of anemia, such as sideroblastic anemia, thalassemia, etc.; (2) Those with liver and kidney dysfunction; (3) Those who are pregnant or breast-feeding, or cannot take contraceptive measures during the test, 3 months before the test and 1 year after taking the drug; (4) Disagree to sign an informed consent form; (5) Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons; (6) Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research); (7) Known allergies to drugs that may be used; (8) Accompanied by severe uncontrollable infection or disease; (9) Patients with any other conditions that the investigator considers inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PLT;RBC;Hb;WBC;Ret %;Fib;D-dimer; | — |
Countries
Chinese
Contacts
Public ContactXuechun Lu
Second Medical Center of Chinese PLA General Hospital
Outcome results
None listed